Financial Performance - YUPELRI net sales reached $62.2 million in Q3 2024, a 7% increase year-over-year, driven by a 14% rise in customer demand and market share growth to 19% in hospitals and 32% in community settings [95]. - TRELEGY global net sales for Q3 2024 were $789 million, representing a 17% year-over-year growth, and total sales for the nine months ended September 30, 2024, were $2.60 billion, reflecting a 30% increase [106]. - The company recognized $16.9 million in revenue from the Viatris collaboration agreement for Q3 2024, an 8% increase year-over-year, and $45.6 million for the nine months ended September 30, 2024, a 15% increase [121]. - As of September 30, 2024, YUPELRI's implied 35% share of net sales was $21.8 million for Q3 and $60.2 million for the nine months ended [95]. - The provision for income tax expense increased by 94% to $(2.6) million for the three months ended September 30, 2024, compared to $(1.4) million in the prior year [134]. - As of September 30, 2024, the company had approximately $91.4 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt [135]. - Net cash used in operating activities was $10.6 million for the nine months ended September 30, 2024, an improvement from $26.1 million in the prior year [139]. - Net cash used in financing activities decreased significantly to $2.1 million for the nine months ended September 30, 2024, compared to $168.3 million in the prior year [144]. Research and Development - Ampreloxetine is in Phase 3 development for treating symptomatic neurogenic orthostatic hypotension in MSA patients, with the first pivotal study not meeting its primary endpoint [97][98]. - The company initiated a Phase 3 clinical study (CYPRESS) for ampreloxetine in MSA patients with symptomatic nOH in Q1 2023, with top-line data expected in mid-2025 [102]. - R&D expenses for Q3 2024 totaled $9.27 million, a 12% increase compared to the prior year, driven by external-related costs associated with the ampreloxetine Phase 3 study [124]. - R&D expenses decreased by $4.1 million for the nine months ended September 30, 2024, compared to the prior year period, primarily due to the discontinuation of investment in research activities [125]. - The company is focused on executing the ampreloxetine registration Phase 3 study and preparing for the NDA filing process [112]. Strategic Initiatives - The company has formed a Strategic Review Committee to explore strategic alternatives aimed at unlocking shareholder value [83]. - The roles of Chair of the Board and CEO have been separated to enhance corporate governance and operational focus [84]. - The company completed the sale of its 85% economic interest in TRELEGY for approximately $1.11 billion, retaining rights to future milestone payments and royalties [104]. - As of September 30, 2024, there are $200 million in potential milestone payments available, with thresholds for the next payments based on TRELEGY global net sales of $2.86 billion and $3.21 billion, representing increases of approximately 4% and 17% compared to 2023 [105]. Product Development and Market Position - The FDA approved YUPELRI in November 2018 for the maintenance treatment of COPD, with ongoing market research indicating a stable demand for nebulized delivery among COPD patients [85]. - The Phase 4 study comparing YUPELRI to Spiriva did not meet its primary endpoint, but YUPELRI maintained an efficacy and safety profile consistent with previous studies [94]. - The company retains worldwide rights to revefenacin in other dosage forms, while Viatris leads commercialization efforts in the US [88]. - In the China Region, the company could receive tiered royalties on net sales of nebulized revefenacin, ranging from 14% to 20% based on annual sales thresholds [93]. - Royalty Pharma invested up to $40 million in ampreloxetine, including a $25 million upfront payment and a $15 million payment upon regulatory approval, with future royalties of 2.5% on sales up to $500 million and 4.5% on sales over that threshold [103]. - The company anticipates TRELEGY to generate global peak sales of $4 billion in 2026 according to Bloomberg consensus estimates [106]. Expenses and Financial Management - Total SG&A expenses were $16.9 million for the three months ended September 30, 2024, representing a 5% increase from $16.1 million in the prior year period [126]. - Excluding share-based compensation, total SG&A expenses for the nine months ended September 30, 2024, were $38.8 million, down from $41.7 million in the prior year, reflecting a 7% reduction [127]. - Non-cash impairment charges of $1.6 million and $4.5 million were recognized for the three and nine months ended September 30, 2024, respectively, related to vacant laboratory space [130]. - Interest expense was $0.6 million and $1.9 million for the three and nine months ended September 30, 2024, respectively, primarily due to non-cash interest associated with $25.0 million received from Royalty Pharma [132]. - Interest and other income decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2024, respectively, due to reduced interest income from cash and marketable securities [133]. Upcoming Events - The company will hold its 2025 Annual General Meeting of Shareholders on May 19, 2025, in Dublin, Ireland [113].

Financial Performance - Theravance Biopharma reported a third-quarter 2024 adjusted net loss of 6 cents per share, which is narrower than the Zacks Consensus Estimate of a loss of 10 cents, compared to an adjusted loss of 1 cent per share in the same quarter last year [1][2] - The total revenues for the quarter were $16.9 million, exceeding the Zacks Consensus Estimate of $16 million, and representing an 8% year-over-year increase due to higher collaboration revenues from partner Viatris [2][4] - The reported loss, including share-based compensation and other expenses, was 26 cents per share, compared to a loss of 17 cents in the year-ago quarter [2] Collaboration and Revenue Sharing - The revenue was entirely derived from Viatris' collaboration revenues related to Yupelri (revefenacin) sales, which is approved for the maintenance treatment of chronic obstructive pulmonary disease [4] - Viatris retains 65% of the profits from Yupelri, while Theravance receives 35%, which includes Theravance's share of net sales and proportionate shared costs [5] Expenses and Financial Guidance - Research and development expenses (excluding share-based compensation) totaled $8.2 million, reflecting a nearly 30% increase from the previous year, while selling, general, and administrative expenses rose around 10% year over year to $13 million [6] - Theravance expects adjusted R&D expenses in the range of $30-$36 million and adjusted SG&A expenses between $45 million and $55 million for 2024 [8] Cash Position - As of September 30, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $91.4 million, down from $96.1 million as of June 30, 2024 [7] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855), a norepinephrine reuptake inhibitor for neurogenic orthostatic hypotension in patients with multiple system atrophy, which has received Orphan Drug designation from the FDA [9] - The phase III CYPRESS study for ampreloxetine began earlier in 2024, with expected completion of patient enrollment by mid-2025 and top-line data anticipated six months post-enrollment [10] Strategic Initiatives - To enhance shareholder value, Theravance has formed a Strategic Review Committee to evaluate all strategic alternatives, including those related to Yupelri and ampreloxetine [11] - In September 2024, Theravance and Viatris reached a settlement with Qilu Pharmaceutical regarding Yupelri, allowing Qilu to produce a generic version starting April 23, 2039, pending regulatory review [12][13]

Financial Data and Key Metrics Changes - Theravance Biopharma reported quarterly net sales for YUPELRI of $62.2 million, reflecting a 7% year-over-year growth and a 14% quarter-over-quarter increase, marking a new launch high [5][11] - Collaboration revenue reached $16.9 million, an 8% increase compared to the previous year, with total operating expenses slightly better than expectations [33][34] - The company closed the period with $91 million in cash and 49 million shares outstanding [35] Business Line Data and Key Metrics Changes - YUPELRI's demand increased by 14% and hospital doses rose by 40% year-over-year, contributing to a nearly 19% market share in the hospital long-acting Neb market [5][17] - Trelegy sales increased by 17% to $789 million for the quarter, with year-to-date sales reaching $2.6 billion, up 30% [22] - Ampreloxetine is progressing well in the CYPRESS study, with patient enrollment on track to meet objectives [26][27] Market Data and Key Metrics Changes - The company is optimistic about YUPELRI's growth potential in the U.S. and has filed an NDA in China, with potential milestones and royalties outlined [20][21] - The strategic objective includes expanding YUPELRI's utilization in the U.S. and exploring opportunities in international markets [39] Company Strategy and Development Direction - The Board has formed a strategic review committee to explore alternatives for unlocking value from key assets, including YUPELRI and Ampreloxetine [9][10] - The company aims to maximize the number of patients benefiting from YUPELRI and is focused on disciplined investment to drive long-term shareholder value [40][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about YUPELRI's growth trajectory and the potential for achieving sales milestones with Trelegy [6][40] - The company is committed to returning excess capital to shareholders and managing expenses carefully to limit cash utilization [10][40] Other Important Information - The company incurred a $1.6 million non-cash impairment charge related to excess lab space [35] - Management highlighted the importance of therapeutic interchange protocols in driving market share for YUPELRI [49] Q&A Session Summary Question: Changes in YUPELRI prescribing patterns post ensifentrine launch - Management noted anecdotal feedback indicating that ensifentrine is being added on to YUPELRI, with a focus on concomitant use [44] Question: Status of site activations for the CYPRESS study - Management confirmed that the majority of key sites are now activated, progressing as planned [45] Question: Drivers of YUPELRI's growth and expectations moving forward - Growth is attributed to formulary approvals and therapeutic interchange, with expectations for continued market share gains [48] Question: Rationale behind the newly formed strategic review committee - The Board is evaluating the company's strategy against both short-term and long-term goals, aiming to unlock value from key assets [50][52] Question: Progress on ASP and expectations for 2025 - Management indicated that improvements in ASP are expected to manifest in early 2025, driven by strong demand growth [56][57]

Core Insights - Theravance Biopharma reported a quarterly loss of $0.06 per share, better than the Zacks Consensus Estimate of a loss of $0.10, representing a 40% earnings surprise [1] - The company generated revenues of $16.87 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 4.71% and showing an increase from $15.69 million year-over-year [2] - The stock has underperformed, losing approximately 19.2% since the beginning of the year, while the S&P 500 has gained 25.8% [3] Financial Performance - Over the last four quarters, Theravance Biopharma has surpassed consensus EPS estimates three times and topped revenue estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.05 on revenues of $34.22 million, and for the current fiscal year, it is -$0.45 on revenues of $79.17 million [7] Market Outlook - The Zacks Rank for Theravance Biopharma is currently 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] - The Medical - Drugs industry, to which Theravance belongs, is currently in the top 27% of Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Third quarter results highlight strong operational performance across key value drivers: YUPELRI® (revefenacin) net sales of $62.2 million, recognized by Viatris, an all-time high, increased 7% versus Q3 2023 and 14% versus Q2 20241 CYPRESS enrollment in-line with expectations, with timelines on track TRELEGY net sales increased 17%, to $789 million, as reported by GSK: Q4 sales of at least ~$260 million needed to earn $25 million milestone2 Q4 sales of at least ~$610 million needed to earn $50 million m ...

DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will report its third quarter 2024 financial results and provide a business update after market close on Tuesday, November 12, 2024. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm EST (2:00 pm PST/10:00 pm GMT) that day.Conference Call InformationTo participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet ma ...

DUBLIN, Oct. 18, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist (LAMA), evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstruc ...

A month has gone by since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 2.2% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Theravance Bio due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Theravance's Q2 Loss Wider Than Expect ...

Core Viewpoint - Theravance Biopharma reported a wider adjusted net loss in Q2 2024 compared to estimates, with total revenues missing expectations despite a year-over-year increase due to collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q2 2024 was 13 cents per share, exceeding the Zacks Consensus Estimate of a loss of 9 cents per share, and matching the loss reported in the same quarter last year [1] - Total revenues were $14.3 million, falling short of the Zacks Consensus Estimate of $16 million, but representing a 4.4% increase year-over-year [2] - The reported loss, including share-based compensation and other expenses, was 34 cents per share [2] Collaboration and Revenue Breakdown - Revenues were entirely derived from collaboration with Viatris related to Yupelri (revefenacin) sales, with Theravance receiving 35% of the profits from this collaboration [3][4] - Viatris recognizes product sales from Yupelri and also holds a stake in Theravance [4] Expense Analysis - Research and development expenses (excluding share-based compensation) totaled $8.8 million, an increase of 17.3% from the previous year [6] - Selling, general and administrative expenses (excluding share-based compensation) decreased by 13.4% year-over-year to $12.9 million [6] Cash Position and Guidance - As of June 30, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $96.1 million, down from $100 million as of March 31, 2024 [7] - The company expects adjusted R&D expenses to be in the range of $30-$36 million and adjusted SG&A expenses between $45 million and $55 million for 2024 [7] - Theravance anticipates that adjusted losses and cash burn for the remainder of 2024 will match the first half of the year, contrary to earlier expectations of breakeven in the second half [8] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855) for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), which has received Orphan Drug designation from the FDA [9] - The phase III CYPRESS study for ampreloxetine began in Q1 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [10]

Financial Data and Key Metrics Changes - The company reported $54.5 million in net sales for YUPELRI, reflecting a 1% year-over-year decrease despite a 43% increase in hospital doses and a 13% increase in overall customer demand [3][8][10] - Collaboration revenue was reported at $14.3 million, representing a 4% year-over-year growth, although this was below internal expectations due to pricing dynamics affecting net sales [29][30] - The company ended the quarter with $96 million in cash and no debt, with operating expenses and cash burn metrics in line with expectations [7][30] Business Line Data and Key Metrics Changes - YUPELRI's net sales performance showed a 1% decline quarter-on-quarter and year-on-year, driven by lower realized net prices due to an evolved channel mix [8][10] - Hospital doses shipped increased by 43% year-on-year, reaching an all-time high, indicating strong demand generation [11] - The company reported an increase in market share for long-acting net market, with hospital share surpassing 18% and community share reaching 32% [12] Market Data and Key Metrics Changes - The company anticipates a more stable pricing environment for YUPELRI in 2025 and beyond, with continued demand growth expected across all patient fulfillment channels [4][10] - The potential introduction of YUPELRI in China is highlighted as a significant opportunity, with the market being the second largest globally for respiratory medications [16][17] Company Strategy and Development Direction - The company aims to grow YUPELRI in the U.S. and sees a clear path forward, focusing on hospital strategies and concomitant messaging to drive adoption [34] - The company is executing a well-designed development regulatory strategy for Ampreloxetine, with expectations for key milestones in the CYPRESS study [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of YUPELRI, despite short-term pricing challenges, and anticipates improvements in pricing dynamics in 2025 [37][50] - The company remains optimistic about achieving significant milestones in the near term, particularly related to Trelegy, with sales trajectory showing positive trends [34] Other Important Information - The company incurred a $3 million non-cash impairment charge due to the write-down in the value of operating lease assets, which is expected to be a one-time charge [30] - The company is managing the CYPRESS study internally to ensure high-quality results and has encountered longer timelines for site activations [20][24] Q&A Session Summary Question: Update on YUPELRI pricing dynamics - Management noted that the channel mix has shifted, impacting gross to net pricing, and anticipates slight price increases in the second half of the year [36][37] Question: Details on channel mix effects - Management explained that varied discounting ranges across different channels contribute to the channel mix dynamics [38][39] Question: Update on Paragraph IV litigations for YUPELRI - Management provided a brief update on ongoing litigation, noting settlements with some litigants and the addition of a new patent for YUPELRI [43][44] Question: Clarification on CYPRESS study timeline - Management confirmed that top-line data from the CYPRESS study is expected approximately six months after the last patient is enrolled in mid-2025 [47][54]